A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants

Healthy Participants Clinical Trial

Official title:

The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016753
• Other study ID #: IM026-021
• Status: Completed
• Phase: Phase 1
• Start date: August 5, 2019
• Est. completion date: February 21, 2020

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• Participants must be a non- smoking genetically female, who has normal renal function, willing to use Loestrin, and of childbearing Potential with intact ovarian function.

• Participants must be healthy, defined as having no clinically significant active or ongoing medical condition Weighing less than or equal to 50 kg and a body mass index between 18.0 and 32.0kg inclusive at screening.

• Participant must have a negative QuantiFeron- TB Gold test at screening and have a normal pap smear result within 3 years.

Exclusion Criteria:

• Participants who are involuntarily incarcerated, have a significant Chronic medical illness or a history of relevant drug allergy to immunologic or related compounds.

• Any serious bacterial, fungal, or viral infection within 3 months or a history of recurrent or chronic infection or Risk for TB.

• A history of any medical condition specifically related to the use of hormonal contraceptives as well as an average intake of more than 21 units of alcohol per week.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986256
30 mg(6ml)
• Loestrin
1.5 mg Norethindrone and 30ug ethinyl estradiol

Locations

Country	Name	City	State
United States	Altasciences Los Angeles (Formerly WCCT Global)	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)		Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Primary	Area under the plasma concentration-time curve over the dosing interval AUC(TAU) of NET		Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Primary	Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)		Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Primary	Area under the plasma concentration-time curve over the dosing interval AUC(TAU)of (EE)		Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Secondary	Incidence of Adverse Events (AEs)		Up to 28 weeks
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 28 weeks
Secondary	Serology clinical lab assessment of blood		up to 28 weeks
Secondary	Hematology clinical lab assessments of blood		up to 28 weeks
Secondary	Urinalysis clinical lab assessment		up to 28 weeks
Secondary	Vital signs of blood pressure		up to 28 weeks
Secondary	Vital signs of body temperature		up to 28 weeks
Secondary	Vital signs of respiratory rate		up to 28 weeks
Secondary	Number of Participants with abnormal physical examination findings		up to 28 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form